Carcinoma, Non-Small-Cell LungPhase 2BRILLIANTNCT02655536
Bevacizumab and Erlotinib in Lung Cancer With Brain Metastases, a Phase II Trial
A Phase 2 study testing Bevacizumab plus erlotinib and Erlotinib in people with Carcinoma, Non-Small-Cell Lung and Brain Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
- What is being tested?
- Bevacizumab plus erlotinib and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed, stage IV (AJCC 7th Edition) non-small cell lung cancer.
- A tumor harboring an EGFR mutation known to be associated with erlotinib sensitivity (exon 19 deletion and L858R)
- Documented brain metastases.
- At least one measure brain lesion and one extracranial lesion
- No emergent operation or radiotherapy is indicated. Patients who have received operation for brain tumor may be enrolled if they have recovered from the operation and there are measurable brain lesions after operation.
- No prior exposure to EGFR inhibitors or anti-angiogenesis therapy including bevacizumab.
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- No prior systemic anti-cancer therapy for advanced NSCLC is allowed. -Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the start of study treatment.
- Written informed consent obtained prior to any screening procedures.
- ≥20 years of age.
- Must have discontinued any previous anti-cancer and investigational therapy for at least 28 days, major operation for at least 28 days with full healing of surgical wounds, or radiotherapy for at least 14 days before study treatment administration, and must have recovered to grade 1 from the adverse effects of such treatment before starting study treatment.
- Life expectancy ≥ 3 months.
- ECOG performance status: 0-1.
- Female patients of child-bearing potential should have a negative pregnancy test.
- Required baseline laboratory status:
- Hemoglobin>9g/dL Platelet count≥100x109/L Absolute neutrophil count (ANC)≥1.5x109/L without growth factor support Total bilirubin>1.5x upper limit of normal (ULN) AST/SGOT and/or ALT/SGPT>2.5x ULN Serum creatinine clearance >50 ml/min, by either Cockcroft-Gault formula or by 24-hour urine collection analysis
- -Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Who cannot join
- Squamous cell carcinoma
- Unable or unwilling to swallow tablet once daily.
- allergy to erlotinib and/or bevacizumab
- Previous treatment of EGFR inhibitors or anti-angiogenesis therapies.
- History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3 months prior to randomization unless definitively treated with surgery or radiation
- Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control the CNS condition.
Show all 34Show fewer
- CNS bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
- Chronic daily use of aspirin (>325 mg/day) or other full-dose NSAIDs with anti platelet activity. Treatment with other antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, and/or cilostazol) is permitted.
- Other baseline laboratory values Uncontrolled hypercalcemia (>11.5 mg/dL) Urinary protein to creatinine ratio >1 (spot urine) Serum creatinine >2.0 ULN
- Radiation therapy within 2 weeks prior to the first dose of study drug. Any persistent side effect of prior radiotherapy must be resolved to grade 1 prior to the first dose of study treatment.
- Any unresolved toxicity from previous anticancer therapy > Grade 1.
- Currently receiving any prohibited medications including vitamins supplements, and herbal supplements.
- Unable to undergo an MRI or contrast CT procedures.
- Active HBV or HCV infection, HBV carrier can be enrolled if HBV DNA titer is low under antiviral treatment.
- Known history of HIV seropositivity. HIV testing is not required as part of this study.
- Undergone a bone marrow or solid organ transplant.
- Another malignancy diagnosed or treated within 5 years, except carcinoma in situ or skin cancer.
- Major surgery within 4 weeks prior to initiating study treatment, excluding the placement of vascular access.
- Cardiac conditions as
- Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy).
- myocardial infarction
- unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible)
- Symptomatic heart failure (NYHA grade II-IV)
- Clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra abdominal abscess
- Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy)
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment, pre-existing idiopathic pulmonary fibrosis or any evidence of clinically active interstitial lung disease.
- Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5mIU/mL).
- Women of child-bearing potential, defined as all women physically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 6 months after stopping study drug. Highly effective contraception methods include:
- Male or female sterilization or
- Combination of any two of the following:
- Use oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS). Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository).
- Women are considered post-menopausal and not of child baring potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Sexually active males must use a condom during intercourse while taking the drug and for 6 more months after stopping study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Oncology, Nationa Taiwan University Hospital
Taipei, 100
Chih-Hsin Yang, M.D.,Ph.D., 886-2-23123456 ext. 67511, chihyang@ntu.edu.tw
About this study
Official title: A Phase II, Open Label, Multicenter Study of Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Patients With EGFR Mutant Non-small Cell Lung Cancer Who Have Brain Metastases
This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.
The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.
Read the detailed description
This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.
The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.
Patients will be randomized, at a 1:1 ratio, into bevacizumab plus erlotinib group or erlotinib alone group. Compute tomography (CT) or MRI scans will be performed every 6 weeks in the first 12 months since start of investigational drugs, and then performed every 12 weeks. Patients will be followed until documented progression at brain and/or extra-cranial lesions. Patients with intracranial progression only are allowed to continue investigational drugs until a second progression of either intracranial progression or extracranial progression, developed, and the time-to extracranial progression will be determined. In patients with EGFR mutant advanced NSCLC who had brain metastases, it was reported that PFS to erlotinib or gefitinib was 6.6 months(Park et al., 2012). In the current study, it is assumed that the median PFS, both intracranial and extracranial included, is 7 months for erlotinib group alone and is 12.3 months for bevacizumab plus erlotinib group (hazard ratio 0.57) (Seto et al., 2014). 109 patients will be required for analysis in this randomized phase II study. Patients will be stratified according to the EGFR L858R mutation and the EGFR exon 19 deletion mutation.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
- Being tested
- Bevacizumab plus erlotinib, Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab plus erlotinibDrug
Also called avastin plus tarceva
Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of every 3 weeks cycle by IV infusion erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
ErlotinibDrug
Also called tarceva
erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab plus erlotinib | Experimental | bevacizumab 15mg/kg every 3 weeks plus erlotinib 150mg per day Receives: Drug: Bevacizumab plus erlotinib |
| erlotinib | Active comparator | erlotinib 150mg per day Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The PFS will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.
Measured: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Secondary outcomes (7)
overall survival
Measured: The survival will be assessed from date of randomization until the date of death from any cause. The survival will be assessed every 3 weeks up to 36 months.
overall response rate
The response rate will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.
Measured: The response rate will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time-to-central nervous system (CNS) progression
The Time-to- CNS progression will be evaluated from date of randomization until the date of documented CNS progression.
Measured: Time-to-central nervous system(CNS) progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time to extra-CNS progression
The Time-to-extra-CNS progression will be evaluated from date of randomization until the date of documented extra-CNS progression.
Measured: Time to extra-CNS progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
The PFS-2 in patients in patients with CNS progression only
The PFS-2 will be evaluated from date of randomization until the date of second documented progression or the date of death from any cause, whichever came first.
Measured: The PFS-2 will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time to neurological symptom progression
Time to neurological symptom will be assessed from date of randomization until the dated of documented progression of neurological symptom.
Measured: Time to neurological symptom progression will be evaluated every 3 weeks up to 36 months.
Number of participants with treatment-related adverse events as assessed by CTCAE version 4.03
Measured: Treatment-related adverse events will be evaluated from date of randomization until 30 days after discontinuation of the trial. It will be evaluated every 3 weeks up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start1 Aug 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655536
- Sponsor's protocol ID
- 201510073MIPB
- Acronym
- BRILLIANT
- Status last verified
- Jul 2018
- First submitted
- 24 Dec 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
PubMed 33067126
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Multicenter Study of Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Patients With EGFR Mutant Non-small Cell Lung Cancer Who Have Brain Metastases
- ClinicalTrials.gov ID
- NCT02655536
- Acronym / sponsor ID
- BRILLIANT / 201510073MIPB
- Conditions
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.
The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.
Detailed description
This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.
The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.
Patients will be randomized, at a 1:1 ratio, into bevacizumab plus erlotinib group or erlotinib alone group. Compute tomography (CT) or MRI scans will be performed every 6 weeks in the first 12 months since start of investigational drugs, and then performed every 12 weeks. Patients will be followed until documented progression at brain and/or extra-cranial lesions. Patients with intracranial progression only are allowed to continue investigational drugs until a second progression of either intracranial progression or extracranial progression, developed, and the time-to extracranial progression will be determined. In patients with EGFR mutant advanced NSCLC who had brain metastases, it was reported that PFS to erlotinib or gefitinib was 6.6 months(Park et al., 2012). In the current study, it is assumed that the median PFS, both intracranial and extracranial included, is 7 months for erlotinib group alone and is 12.3 months for bevacizumab plus erlotinib group (hazard ratio 0.57) (Seto et al., 2014). 109 patients will be required for analysis in this randomized phase II study. Patients will be stratified according to the EGFR L858R mutation and the EGFR exon 19 deletion mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab plus erlotinib | Experimental | Drug: Bevacizumab plus erlotinibbevacizumab 15mg/kg every 3 weeks plus erlotinib 150mg per day |
| erlotinib | Active comparator | Drug: Erlotiniberlotinib 150mg per day |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically confirmed, stage IV (AJCC 7th Edition) non-small cell lung cancer.
- A tumor harboring an EGFR mutation known to be associated with erlotinib sensitivity (exon 19 deletion and L858R)
- Documented brain metastases.
- At least one measure brain lesion and one extracranial lesion
- No emergent operation or radiotherapy is indicated. Patients who have received operation for brain tumor may be enrolled if they have recovered from the operation and there are measurable brain lesions after operation.
Key exclusion criteria (34 listed)
- Squamous cell carcinoma
- Unable or unwilling to swallow tablet once daily.
- allergy to erlotinib and/or bevacizumab
- Previous treatment of EGFR inhibitors or anti-angiogenesis therapies.
- History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3 months prior to randomization unless definitively treated with surgery or radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab plus erlotinibAlso: avastin plus tarcevaBevacizumab will be administered at a dose of 15 mg/kg on day 1 of every 3 weeks cycle by IV infusion erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle | Drug | bevacizumab plus erlotinib |
| ErlotinibAlso: tarcevaerlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle | Drug | erlotinib |
Primary outcome
Progression-free survival
Time frame: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
The PFS will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.
7 secondary outcomes
overall survival
Time frame: The survival will be assessed from date of randomization until the date of death from any cause. The survival will be assessed every 3 weeks up to 36 months.
overall response rate
Time frame: The response rate will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time-to-central nervous system (CNS) progression
Time frame: Time-to-central nervous system(CNS) progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time to extra-CNS progression
Time frame: Time to extra-CNS progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
The PFS-2 in patients in patients with CNS progression only
Time frame: The PFS-2 will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.
Time to neurological symptom progression
Time frame: Time to neurological symptom progression will be evaluated every 3 weeks up to 36 months.
Number of participants with treatment-related adverse events as assessed by CTCAE version 4.03
Time frame: Treatment-related adverse events will be evaluated from date of randomization until 30 days after discontinuation of the trial. It will be evaluated every 3 weeks up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Derived from this study: PubMed 33067126Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab plus erlotinib and Erlotinib in people with Carcinoma, Non-Small-Cell Lung and Brain Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.